Rheumatism and Dietetic: RHUMADIET Study (Food Practices and Beliefs)

Completed

• Conditions: Rheumatoid Arthritis; Axial Spondyloarthritis; Hand Osteoarthritis

• Registration Number: NCT03770884
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

Cross sectional study assessing food practices and beliefs in RA, AS and DA (digital arthritis)

Detailed Description

To investigate in patients having rheumatoid arthritis (RA), or axial spondyloarthritis (AS) or digital osteoarthritis (DA) practices and beliefs about influence of food and diet on their rheumatic disease.

200 patients of each disease will be included in this cross-sectional non interventional study Factors associated with specific practices or specific beliefs will be determined.

Only questionnaires are used in this study.

Study Timeline

• Study First Submitted: 2018-07-09
• Study First Submitted QC: 2018-12-06
• Study First Posted: 2018-12-10
• Study Start: 2019-01-08
• Primary Completion: 2019-04-18
• Study Completion: 2019-04-18
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-31
• Last Update Posted: 2021-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 448

Inclusion Criteria

• Over 18 years of age
• Rheumatoid arthritis (RA) according to ACR/EULAR criteria or axial spondyloarthritis (AS) according to ASAS 2009 criteria or digital osteoarthritis (DA) according to ACR criteria.

Exclusion Criteria

• Severe upper functional or psychiatric disorders
• Patients under guardianship or trusteeship
• Patients unable to answer the questionnaire in French

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients who follow or have followed at least one diet for their rheumatic disease among gluten-free, cow's milk, lactose-free, vegetarian, vegan, Seignalet, Mediterranean, fasting period	10 minutes	Binary criterion: Diet follower Yes/No

Secondary Outcome Measures

Name	Time	Method
For each type of food, prevalence of patients with RA considering that the food influences the rheumatic pain in each rheumatic disease	10 minutes	for each type of food (meat, vegetables, fruits, grains, nuts, fish, alcohol, soda), prevalence of patients with RA considering that food influence their disease symptoms
comparison between each rheumatism rheumatoid arthritis, Axial spondyloarthritis digital osteoarthritis of the prevalence of patients having followed or following one or more diets	10 minutes	Proportion of diet follower patients in RA versus AS versus DA. Specific food and diet questionnaires will be used in this study.
Research of socio-demographic or rheumatic factors associated with dieting in AS.	10 minutes	In AS population: Unajusted and adjusted risk of diet (odds ratio) assiociated with the following factors reported from patient file or patient questionnaires.; * Sociodemorgraphic parameters:Age, gender, education level.; * Physiologic parameters: BMI; * Clinical parameters: treatments, disease activity using BASDAI Scale
For each type of food, prevalence of patients with AS considering that the food influences the rheumatic pain in each rheumatic disease	10 minutes	for each type of food (meat, vegetables, fruits, grains, nuts, fish, alcohol, soda), prevalence of patients with AS considering that food influence their disease symptoms
For each type of food, prevalence of patients with DA considering that the food influences the rheumatic pain in each rheumatic disease	10 minutes	for each type of food (meat, vegetables, fruits, grains, nuts, fish, alcohol, soda), prevalence of patients with DA considering that food influence their disease symptoms
Research of socio-demographic or rheumatic factors associated with dieting in RA.	10 minutes	In RA population:Unajusted and adjusted risk of diet (odds ratio) assiociated with the following factors reported from patient file or patient questionnaires.; * Sociodemorgraphic parameters:Age, gender, education level.; * Physiologic parameters: Autoantibody status, BMI; * Clinical parameters: treatments, disease activity using DAS 28 scale.
Research of socio-demographic or rheumatic factors associated with dieting in DA.	10 minutes	In DA population: Unajusted and adjusted risk of diet (odds ratio) assiociated with the following factors reported from patient file or patient questionnaires.; * Sociodemorgraphic parameters: Age, gender, education level.; * Physiologic parameters: BMI; * Clinical parameters: treatments, disease activity using 0-100mm visual analogic scale

Trial Locations

Locations (1)

Service de Rhumatologie - Hôpital Saint Antoine; 🇫🇷 Paris, France